Association Between Sleep and Psychomotor Development in Early Childhood

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

119 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-12-01

Brief Summary

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Sleep is a neurophysiological active process essential for healthy physical and cognitive development. In Portugal, there is no recent and objective data on how children sleep.

Given the importance of sleep in child health and development as well as the health gains achieved by establishing healthy sleep patterns since childhood, it seems extremely relevant to assess the various sleep parameters of Portuguese children and correlate them with their psychomotor and anthropometric development indicators. The results of this research work may support the implementation of sleep health education measures among parents, educators and policy makers, thus contributing to support the implementation of practices that promote sleep quality, napping until later in life as well as to promote the health of future adults.

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Detailed Description

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Conditions

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Sleep

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy children

Aged 2 to 4 years old

Actigraphy

Intervention Type OTHER

Actigraphy is a validated complementary means of diagnosis, the gold standard for the assessment of circadian rhythm.

Schedule of Growing Skills II

Intervention Type OTHER

Assessment scale for skills in child development from 0 to 6 years.

Questionnaire Children Sleep habits

Intervention Type OTHER

Questionnaire for assessing sleep habits, validated for the Portuguese population (4) which allows us to understand the sleep hygiene habits of the child

Melatonin evaluation

Intervention Type OTHER

Melatonin will be measured in the first-morning urine and it is considered to be a good marker of plasma MLT level since its concentration is highly correlated with nocturnal plasma melatonin.

Interventions

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Actigraphy

Actigraphy is a validated complementary means of diagnosis, the gold standard for the assessment of circadian rhythm.

Intervention Type OTHER

Schedule of Growing Skills II

Assessment scale for skills in child development from 0 to 6 years.

Intervention Type OTHER

Questionnaire Children Sleep habits

Questionnaire for assessing sleep habits, validated for the Portuguese population (4) which allows us to understand the sleep hygiene habits of the child

Intervention Type OTHER

Melatonin evaluation

Melatonin will be measured in the first-morning urine and it is considered to be a good marker of plasma MLT level since its concentration is highly correlated with nocturnal plasma melatonin.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children aged 2 and 6 months year until the first assessment;
* Gestational age at birth 37 weeks or more;
* Delivery without serious complications for the child;
* Absence of developmental pathologies or pathologies that interfere with psychic and motor development;

Exclusion Criteria

* Non-preterm birth but with severe growth restriction;
* Diagnosis of psychomotor development pathology;
* Diagnosis of pathology that interferes with psychomotor development;
* Taking daily medication, except vitamin supplements.

Minimum Eligible Age

2 Years

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes